BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    MDR report key: 22809332 · Received August 14, 2025

    Report

    Report Number
    3004753838-2025-223107
    Event Type
    Malfunction
    Date Received
    August 14, 2025
    Date of Event
    July 17, 2025
    Report Date
    January 30, 2026
    Manufacturer
    DEXCOM, INC.
    Product Code
    QBJ
    UDI-DI
    00386270002525
    PMA / PMN Number
    K213919
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MFR # 3004753838-2025-223107 WAS REPORTED IN ERROR. PLEASE DISREGARD INITIAL REPORTING OF THIS EVENT AS THIS EVENT HAS NOW BEEN DEEMED NOT REPORTABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). B5: DESCRIBE EVENT OR PROBLEM - ADDITIONAL INFORMATION. H2 TYPE OF FOLLOW UP: ADDITIONAL INFORMATION. H3: DEVICE EVALUATED BY MFG - ADDITIONAL INFORMATION. H6: ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    SUBSEQUENT TO THE INITIAL MDR, IT WAS DETERMINED THAT A REPORT WAS SUBMITTED IN ERROR. UPON FURTHER REVIEW, IT WAS DETERMINED THAT THE PATIENT ALLEGATION DOES NOT MEET THE CRITERIA OF A REPORTABLE EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. THE PRODUCT WAS EVALUATED. AN EXTERIOR VISUAL INSPECTION WAS PERFORMED AND PASSED. RECEIVER CHARGE AND BOOT TESTS WERE PERFORMED AND PASSED. FUNCTIONAL TEST WAS PERFORMED AND FAILED. AUDIO TEST; SERIAL NUMBER VERIFICATION WAS PERFORMED AND FAILED. ALARM/ALERT MANUAL TEST WAS PERFORMED AND FAILED. SPEAKER/VIBRATOR RESISTANCE WAS PERFORMED AND PASSED. INTERNAL VISUAL INSPECTION WAS PERFORMED AND FAILED. THE PERFORMANCE DATA WAS REVIEWED FINDING ASSEMBLY ERROR RELATED TO THE COMPLAINT. THE ALLEGATION WAS CONFIRMED AS NO AUDIO OUTPUT. THE PROBABLE CAUSE WAS DETERMINED TO BE ASSEMBLY ERROR VIA PRODUCT. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT AN ALERT/NOTIFICATION SETTINGS ISSUE OCCURRED. PRODUCT HAS BEEN RECEIVED BUT IS PENDING EVALUATION. A FOLLOW UP REPORT WILL BE SUBMITTED UPON COMPLETION. NO INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865990 DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM CONTINUOUS GLUCOSE MONITOR QBJ DEXCOM, INC. 16909434 00386270002525

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female TRESIBA